MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS PWR HIGH SPEED DRILL; SAW, POWERED, AND ACCESSORIES

Catalog Number 7209391

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).No evaluation conducted to date, awaiting receipt of device.

Event Description

It was reported that the drill is heating up rapidly due to very excessive current draw.Event did not occur during a procedure.No injuries or complications were noted.

Manufacturer Narrative

The device was received and sent to the original equipment manufacturer (oem) for evaluation.There was no relationship found between the returned device and the reported incident.An evaluation of the device performed by the oem found that the device passed all testing.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.

• Brand Name: DYONICS PWR HIGH SPEED DRILL
• Type of Device: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• Manufacturer Contact: jim gonzales ; 7000 w william cannon dr; austin, TX 78735
• MDR Report Key: 6752389
• MDR Text Key: 81420121
• Report Number: 3003604053-2017-00079
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Catalogue Number: 7209391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1